Senior eClinical Business Lead, IRT & DHT Design Consultant

Key Accountabilities:

Project Delivery

• Provide consultation to Project Leaders and other study team members on RTSM and DHT (Digital Health Technology) study design.

• Analyze protocols and collaborate with all stakeholders to create and review user Requirements and ensure they meet the needs of the study design.

• Identify and mitigate any risks related to RTSM and DHT study design.

• Translate complex RTSM and DHT requirement descriptions into language that can be understood by study team to aid in their decision making and understanding of project functionality.

• Understand the various integrations that can interface with RTSM and DHT and proactively help identify any potential integration user requirements issues.

• Work closely with UAT Leads.

• Stay current on RTSM and DHT technology and relevant clinical trial process developments in the industry and requirements within Parexel.

• Manage quality control and timely delivery of project deliverables and appropriate remedial action.

Client Management

• Interact with external clients as needed for discussion on RTSM and DHT design and protocol elements.

• Demonstrate a proactive approach to providing solutions in a timely manner.

General Administration

• Maintain a working knowledge of applicable ICH Guidelines and Good Clinical Practices.

• Complete routine administrative tasks in a timely manner (e.g., timesheets, training) and in compliance with relevant guidelines.

Skills and Experience:

• 5+ years of experience in building RTSM and/or DHT clinical trial systems and developing user requirement with detailed understanding of requirements gathering, configuration, design, and user acceptance testing.

• Excellent technical and data standard experience.

• Proven awareness and experience in the use of data standards within a clinical trial environment; knowledge of industry standards such as CDISC SDTM is preferred.

• Ability to create and explain business process and train others on that process.

• Strong analytical and problem-solving skills.

• Ability to resolve issues independently with good judgement to escalate appropriately.

• Client focused and demonstrating an ability to create and maintain trust with the client.

• Knowledgeable in ICH and GCP regulations in relevant geographies.

• Personal leadership, prioritization and management of own workload.

• Ability to conduct root cause analysis in business problem solving and process improvement development.

• Excellent interpersonal, verbal, and written communication skills.

• Knowledge in clinical research industry, including expert understanding of clinical technology, RTSM design, and system requirements.

• eCOA, ePRO experience is a plus.

Education:

• Bachelor's degree in Life Sciences, Computer Science, or a related field, or equivalent experience.